Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia : Impact on Block Characteristics, on Acute and Chronic Postoperative Pain
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia
研究概览
简要总结
Neuraxial blocks are usually used as an anaesthetic method for urogynecological surgeries. In most patients under regional anaesthesia, premedication is given for reducing anxiety. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of dexmedetomidine vs remifentanil for sedation in patients under spinal anaesthesia for urogynecological procedures.
详细描述
The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include ECG, noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). A peripheral intravenous catheter wil be placed for fluid replacement ( Ringer's Lactate solution 6 - 8ml/ kg/hr) and administration of drugs.
Women will be randomly assigned into one of two groups:
Group A: Women will receive dexmedetomidine continuously infused at a dose of 0,6 mcg/kg for 10 minutes (concentration of the solution 6mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia.
Group B: Women will receive remifentanil continuously infused at a dose of 1mcg/kg for 10 minutes (concentration of the solution 1mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia.
The insertion of a 27 Gauge (27G) spinal needle is performed at L3-L4 or L4-L5 interspace, in the lateral position. All patients will receive 2,7 ml ropivacaine 0,75% and 15 mcg fentanyl intrathecally and assessment of sensory and motor block will be assessed every 2 min. The moment that sensory block is in the highest dermatome and motor block is complete (Bromage grade 3) is Time to max effect (Tmax). In group A an infusion of dexmedetomidine (6mcg/ml) at a dose of 0,6mcg/kg/hr will be administered and in group B an infusion of remifentanil (1mcg/ml) at a dose of 0,03 mcg/kg/min.At the end of the surgery patients will be transferred in Post Anaesthetic Care Unit (PACU) and a patient control analgesia (PCA) pump will be provided to the patient, administering 1 mg of morphine in every attempt, with a lock out interval of 10 minutes.There will be no continuous infusion. All patients will receive a standardized multimodal approach, including diclofenac 50 mg t.i.d, paracetamol 1gr as rescue analgesia (max 4 gr per day) and PCA with morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All syringes and solutions will be prepared by an independent researcher who will not be further involved in the study eg data collecting or analyzing them.All syringes will look identical to the anesthetist who will administer them to the patients.Apart from the anesthetist, the surgery staff and the researchers recording the measurements will not know the therapeutic intervention team in which each patient has been randomized.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Physical status according to American Society of Anesthesiologists (ASA) I-II
- •Patients scheduled for transvaginal urogynecological or gynecological surgery
排除标准
- •Patient refusal
- •Contraindication of spinal anaesthesia (Coagulopathy, Local infection at the site of injection, Local anaesthetic allergy, Hypovolaemia)
- •BMI > 30 kg/m2
- •Personal history of cardiovascular disease
- •Arrythmias
- •Conduction disorders
- •Severe kidney or liver dysfunction
- •Insulin-dependent diabetes mellitus
- •Central nervous system disorders
- •Psychiatric and mental status disorders
- •Chronic Excessive Alcohol Consumption
- •Chronic Use of Opioid Analgesics
- •Chronic Use of corticosteroids
- •Chronic Use of clonidine (or other a2 adrenergic agonist)
- •Use of drugs acting on central nervous system or analgetics the last two weeks
- •Communication problems due to language barriers or unable to understand the pain scale
研究组 & 干预措施
Group DEX
Intravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.6 mcg / kg / h.
干预措施: Dexmedetomidine (Drug)
Group REMI
Intravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.025 mcg / kg / min.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Duration of postoperative analgesia
时间窗: 24 hours postoperatively
Time for first analgesia / PCA first bolus
次要结局
- Analgesic consumption(0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively)
研究者
Staikou Chryssoula
Assistant Professor of Anesthesiology
University of Athens